Strategic and Effective FDA Pre-Submissions

Posted By on Jul 1, 2015 | 10 comments


The purpose of the FDA Pre-Submission Program* (formerly Pre-IDE) and Meeting with FDA  is to provide a mechanism for applicants through which they can request feedback from the Food and Drug Administration (FDA) regarding potential or planned

1) Medical device Investigational Device Exemption (IDE) applications,

2)  Premarket Approval (PMA) applications,

3) Humanitarian Device Exemption (HDE) applications,

4) De novo Petitions (Evaluation of Automatic Class III Designations ),

5) Premarket Notification (510(k)) Submissions,

6) Clinical Laboratory Improvement Amendments (CLIA) Waiver by Application,

FDA Feedback may include

a) Written feedback by email

b) Conference call (max 1 hour)

c) Face-to-Face Meeting (max 1 hour)

For #a and #b – Meeting minutes must be drafted and submitted for FDA review.  Approved minutes become part of the Pre-Submission record

Contact Glen Feye -FDA regulatory consultant– at glen@accuratefdaconsultanting for help with planning, submitting and leading Pre Submission meeting

*Per 2012 Draft FDA Guidance titled- The Pre-Submission Program and Meetings with Food and Drug Administration Staff

10 Comments

  1. Sorry- but ACI is not involved in makeup, unless there is a SPF factor-then it is considered a OTC drug

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    • Thanks We specialize in providing excellent services to the medical device, IVD, biologic and pharmaceutical industries

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  4. Muchos Gracias for your blog.Much thanks again. Fantastic.

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    • Pre-Submissions are essential to a successful medical device FDA regulatory submission

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